Catheter Assembly Including Transitioning Lumens

ABSTRACT

A catheter assembly including an elongate catheter tube is disclosed. The number of lumens defined by the catheter tube can vary as a function of longitudinal length along the catheter tube. For instance, the catheter tube can define three lumens from the proximal end of the catheter tube and terminate one of the lumens at an intermediate termination point such that only two lumens are defined further distally along the catheter tube. A sensor can be placed in the terminating lumen so as to isolate it from the other lumens and from blood or other body fluids while still enabling the sensor to reside within the patient body when the catheter tube is positioned in the patient for use. In addition to this, various other lumen transition and sensor configurations are disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/313,047, filed Mar. 24, 2016, and titled “CatheterAssembly Including Transitioning Lumens,” which is incorporated hereinby reference in its entirety.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toa catheter assembly that includes one or more sensors that can detectand/or monitor various functions, characteristics, and/or vitalmeasurements of a body of a patient in which the catheter assembly isplaced. The sensors are placed in various positions in, on, orassociated with the catheter assembly. For instance, one or more sensorscan be placed so as to be in communication with one or more lumensdefined by a catheter tube of the catheter assembly so as to be incontact with fluids present in the lumen(s). Yet other sensors areconfigured to be in proximity to the patient body but not in fluidcommunication therewith. Other locations are also possible andcontemplated.

In one embodiment, the number of lumens defined by the catheter tube canvary as a function of longitudinal length along the catheter tube. Forinstance, the catheter tube can define three lumens from the proximalend of the catheter tube and terminate one of the lumens at anintermediate termination point such that only two lumens are definedfurther distally along the catheter tube. The terminating lumen in thiscase can merge with one of the other two lumens, or can simply end at apredetermined longitudinal length along the catheter tube. A sensor canbe placed in the terminating lumen so as to isolate it from the otherlumens and from blood or other body fluids while still enabling thesensor to reside within the patient body when the catheter tube ispositioned in the patient for use. In addition to this and as will beshown further below, various other lumen transition and sensorconfigurations are possible.

In one embodiment, therefore, a catheter assembly is disclosed,comprising an elongate catheter tube defining at least onefluid-carrying lumen extending between a proximal end and a distal endof the catheter tube. The catheter tube further defines at least oneterminating lumen defined by the catheter tube. The terminating lumendistally extends to a closed distal termination point positionedintermediately between the proximal and distal ends of the cathetertube. The termination point is defined by the catheter tube material.The terminating lumen is configured to be isolated from fluids.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a side view of a catheter assembly including a plurality ofsensors in accordance with one embodiment;

FIG. 2 is a side view of a catheter tube according to one embodiment;

FIGS. 3A-3C depict various views of the catheter tube of FIG. 2;

FIG. 4 is a side view of a catheter tube according to one embodiment;

FIGS. 5A and 5B show cross-sectional views of the catheter tube of FIG.4 according to one embodiment;

FIGS. 6A and 6B show cross-sectional views of the catheter tube of FIG.4 according to one embodiment;

FIGS. 7A and 7B show cross-sectional views of the catheter tube of FIG.4 according to one embodiment;

FIG. 8 is a cross sectional side view of a catheter tube including adistally-located sensor according to one embodiment;

FIG. 9 is a cross-sectional view of a catheter tube with an includedsensor lumen in accordance with one embodiment;

FIG. 10 is a cross-sectional view of a catheter tube with an includedsensor lumen in accordance with one embodiment;

FIG. 11 is a cross-sectional view of a catheter tube with an includedsensor wire configuration in accordance with one embodiment;

FIG. 12 is a cross sectional side view of a catheter tube including adistally-located sensor according to one embodiment;

FIG. 13 is a cross sectional side view of a catheter tube including adistally-located sensor according to one embodiment;

FIG. 14 is a cross sectional side view of a catheter tube including adistally-located sensor according to one embodiment;

FIG. 15 is a cross-sectional view of a catheter tube with an includedsensor lumen in accordance with one embodiment;

FIG. 16 is a cross-sectional view of a catheter tube with an includedsensor lumen in accordance with one embodiment;

FIG. 17 is a cross-sectional view of a catheter tube with an includedsensor lumen in accordance with one embodiment;

FIG. 18 is a cross-sectional view of a catheter tube with an includedsensor wire configuration in accordance with one embodiment;

FIG. 19 is a cross-sectional view of a catheter tube with an includedsensor wire configuration in accordance with one embodiment; and

FIG. 20 is a cross-sectional view of a catheter tube with an includedsensor wire configuration in accordance with one embodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present invention are generally directed to acatheter assembly that includes one or more sensors that can detectand/or monitor various functions, characteristics, and/or vitalmeasurements of a body of a patient in which the catheter assembly isplaced. The sensors are placed in various positions in, on, orassociated with the catheter assembly. For instance, one or more sensorscan be placed so as to be in communication with one or more lumensdefined by a catheter tube of the catheter assembly so as to be incontact with fluids present in the lumen(s). Yet other sensors areconfigured to be in proximity to the patient body but not in fluidcommunication therewith. Other locations are also possible andcontemplated.

In accordance with one embodiment, the number of lumens defined by thecatheter tube can vary as a function of longitudinal length along thecatheter tube. For instance, the catheter tube can define three lumensfrom the proximal end of the catheter tube and terminate one of thelumens at an intermediate termination point such that only two lumensare defined further distally along the catheter tube. The terminatinglumen in this case can merge with one of the other two lumens, or cansimply end at a predetermined longitudinal length along the cathetertube. A sensor can be placed in the terminating lumen so as to isolateit from the other lumens and from blood or other body fluids while stillenabling the sensor to reside within the patient body when the cathetertube is positioned in the patient for use. In addition to this and aswill be shown further below, various other lumen transitionconfigurations are possible.

In yet another embodiment, various catheter tube lumen configurationsare disclosed that enable a sensor to be placed proximate the distal endof the catheter tube, with an accompanying sensor wire(s) extending fromthe proximal end of the catheter tube to the distally-disposed sensor soas to provide for functionality of the sensor. The sensor wires can beprovided a pathway via a dedicated sensor wire lumen, or byincorporation into the catheter tube wall of septum, in one embodiment.These pathways are provided in addition to one or more functionalinfusion/aspiration lumens also defined by the catheter tube. Placementof the sensor in this manner enables the sensor to be located within thepatient body and proximate a desired location while still being includedas part of the catheter assembly.

Reference is first made to FIG. 1, which depicts various details of acatheter assembly (“catheter”), generally designated at 10, inaccordance with one embodiment. As shown, the catheter 10 includes anelongate catheter tube 12 defining one or more lumens 14 extendingbetween a proximal end 12A and a distal end 12B thereof. The proximalend 12A of the catheter tube is operably connected to a bifurcation hub(“hub”) 16, which in turn is operably connected to one or more extensionlegs 18. A connector 20, such as a luer connector, is disposed on aproximal end of the extension leg 18. The hub 16 includes two suturewings 22 that oppositely extend from the body of the hub 16. Each suturewing 22 includes a suture hole 24. Note that the hub 16 is also referredto herein as a “bifurcation hub” even in cases where only one fluidpassageway is defined therethrough.

In accordance with one embodiment, one or more sensors, also referred toherein as a “sensor array” 30, are included with the catheter 10 toenable the detection of data relating to one or more physiologicalaspects of the patient and/or physical aspects of the catheter when thecatheter tube 12 is disposed in the vasculature (as discussed here) orother suitable internal portion of the body of the patient. In thepresent embodiment, multiple sensors are included with the catheter 10,though the number, type, size, placement, function, and desired uses ofthe various sensors can vary from what is shown and described herein.Note that the sensor array 30 can, in one embodiment, include only onesensor. Note also that, where only one of a particular sensor isdiscussed below, it is appreciated that more than one of a particulartype of sensor can be included, in the same or different locationswithin the catheter assembly.

As shown in FIG. 1, a pressure sensor 32 is included as part of thesensor array 30. In the present embodiment, the pressure sensor 32includes a central venous pressure (“CVP”) sensor and is disposed so asenable venous pressure of the patient to be sensed via the fluid (suchas blood and/or saline) typically present within the lumen 14 of thecatheter tube 12. As shown, in the present embodiment the pressuresensor 32 is disposed within the hub 16 so as to be in operablecommunication with a fluid passageway 26 within the hub that is in turnin fluid communication with the lumen 14 of the single-lumen cathetertube 12 shown in FIG. 1. Other pressure sensor locations can alsoemployed, including within the catheter tube 12, the extension leg 18,etc. In one embodiment, the pressure sensor 32 is a medical pressuresensor NPC-100 or NPC-120, manufactured by Amphenol Corporation, thoughother pressure sensors may also be employed. In another embodiment, thepressure sensor includes a strain-sensitive Wheatstone bridge. Thesensing surface of the pressure sensor 32 in the present embodiment isin direct contact with fluid present in the fluid passageway of the hub16. Note that the size, shape, and other configuration of the hub 16 maybe increased from what is shown and described herein in order toaccommodate the sensor array 30, in one embodiment.

An ECG sensor 34, also referred to herein as an ECG electrode orelectrical sensor, is also included with the catheter assembly to enableECG signals emanating from the heart of the patient to be detected, inconjunction with an additional ECG sensor/electrode located on thepatient's skin or external portion of the catheter assembly/proximatethe catheter assembly, in one embodiment. As shown, in the presentembodiment the ECG sensor 34 is also disposed within the hub 16 so as tobe in direct contact with fluid present in the hub fluid passageway 26and the lumen 14 of the catheter tube 12. Other ECG sensor locations canalso be employed, including within the catheter tube 12, the extensionleg 18, etc. In the present embodiment, the ECG sensor 34 includes aconductive wire that is able to detect ECG signals of the patient heartthat are present in the fluid of the hub fluid passageway 26 andcatheter tube lumen 14, though other types of ECG sensors can beemployed. Further details regarding a system and method for using an ECGsensor for guiding the catheter assembly to a desired position withinthe body of a patient can be found in U.S. Pat. No. 8,849,382, entitled“Apparatus and Display Methods Relating to Intravascular Placement of aCatheter,” which is incorporated herein by reference in its entirety.

As described, the sensor array 30—including here the pressure sensor 32and the ECG sensor 34—is disposed within the hub 16, which is sized toprovide the needed volume for such sensors. Note that the size, shape,and configuration of the hub 16 can vary from what is shown anddescribed in order to house the sensor(s). In other embodiments, thesensors can be located in other portions of the catheter 10, includingalong or at either end of the catheter tube 12, the extension leg(s) 18,etc. Also note that a variety of sensors for detecting bodymeasurements, physiological aspects of the patient, and/or physicalaspects of the catheter can be included with the catheter assembly, someof which are discussed further below.

FIG. 1 further shows that the hub 16 (or other suitable location)includes a printed circuit board (“PCB”) 36 that is configured to governoperation of the sensor array 30, here including the pressure sensor 32and the ECG sensor 34. In one embodiment, the PCB 36 includes amicroprocessor for governing sensor operation. In one embodiment, thePCB 36 can further include a power source for powering the sensor array30, though in other embodiments the power source can be remotelydisposed from the PCB, and even the catheter 10. A non-volatile memorystorage location, such as flash memory for instance, can also beincluded on the PCB 36 to enable data sensed by the sensors of thesensor array 30 to be temporarily or permanently stored thereon. Thestorage location can be accessible by a user or can be transmitted to adesired location in a suitable manner.

In the present embodiment, the PCB 36 further includes a transmissionmodule, such as a radio for enabling the PCB to transmit sensor datawirelessly to another receipt location, such as those referred tofurther above. Such wireless transmission can occur via Bluetooth,Wi-Fi, rF, near-field communication (“NFC”), GPS, ANT, ZigBee, or othermanner utilizing electromagnetic radiation. In another embodiment, thesensor data can be transmitted from the catheter 10 via a physicalconnection, such as via a removable physical connection, wires, etc. Inanother embodiment and as mentioned, sensor data, e.g., central venouspressure, ECG signals, temperature, etc., are stored in a memorylocation included on the PCB 36, or other location on the catheter 10.In yet another embodiment, the PCB 36 includes a clock/timer circuit.

In the present embodiment of FIG. 1, the suture holes 24 of the suturewings 22 are configured to include electrical contacts to provide powerto the sensors 32 and 34 of the sensor array 30, as well as to the PCB36. In particular, an annular electrical contact 40 is included in eachsuture hole 24 of the bifurcation hub suture wings 22, with theelectrical contacts being operably connected to the PCB 36 and sensorarray 30. A securement device is configured to be placed on the skin ofthe patient and operably connect with and secure in place the catheter10 once the distal portion of the catheter has been inserted into thepatient. To that end, the securement device in one embodiment includes aretainer mounted to an adhesive pad, and securement arms that are hingedso as to removably pivot atop the suture wings 22 of the bifurcation hub16 (in a snap-fit arrangement) to secure the bifurcation hub in place.

In one embodiment, the securement device 50 includes additionalfunctionality to provide power to the sensor array 30 and PCB 36. Indetail, the securement device can include two posts, each of which isconfigured to serve as an electrical contact and each of which isoperably connected with a battery, also included in the securementdevice. The posts are configured to be received within the correspondingsuture holes 24 of the catheter suture wings 22 such that electricalcontact is established with the electrical contacts 40 of the sutureholes. The battery included on the securement device can, in this way,provide electrical power to the sensors 32, 34 and the PCB 36 of thecatheter hub 16. Of course, other external power sources can beemployed. In one embodiment, electrical contacts between the catheterand the securement device can also be utilized to transfer sensor datatherebetween. In another embodiment, the securement device can include aradio or other mode for transmitting sensor data received from thecatheter. In yet another embodiment, the PCB or a sensor can be includedon the securement device. It is appreciated that the size, shape, andother configuration of the securement device can vary from what is shownand described herein. Further details regarding the catheter assembly 10with one or more included sensors can be found in U.S. patentapplication Ser. No. 15/275,059, filed Sep. 23, 2016, and entitled“Catheter Assembly Including Monitoring Capabilities,” which isincorporated herein by reference in its entirety. Note that theprinciples discussed in the present disclosure can be employed incatheters and elongate tubular devices that include no sensor, or one ormore sensors as may be appreciated.

Though shown in FIG. 1 as a dual lumen catheter assembly in theconfiguration of a PICC, it should be appreciated that this is but oneexample of a catheter that can benefit from the teachings herein.Indeed, catheters and elongate tubular devices of various types canemploy the teachings disclosed herein, including PICCs, CVCs, dialysiscatheters, Foley and urinary catheters, feeding tubes, arterialcatheters, balloon catheters, PIVs, etc.

Together with FIG. 1, reference is now made to FIGS. 2 and 3A-3C. Indetail, FIG. 2 depicts a portion of the catheter tube 12 of the catheterassembly 10 of FIG. 1, wherein the catheter tube includes areduced-diameter portion 300, wherein the outer diameter of the cathetertube 12 is reduced relative a more proximal un-reduced portion of thecatheter tube. In accordance with one embodiment, the number of lumens14 defined by the catheter tube 12 varies along the longitudinal lengthof the catheter tube. As seen in FIG. 3A, which shows a cross-sectionalview of the catheter tube 12 taken along section A-A (FIG. 2), thecatheter tube defines three lumens 14A, 14B, and 14C in a proximalportion of the catheter tube, such as the portion extending distallyfrom the hub 16 to a proximal end 300A of the reduced diameter portion300.

FIG. 3B shows that substantially at the proximal end 300A of the reduceddiameter portion 300, lumen 14C is closed and the area formerly occupiedby the lumen becomes part of a catheter tube wall 302, indicated by atube wall region 301 in FIG. 3B. Indeed FIG. 3B, which is across-sectional view of the catheter tube 12 of FIG. 2 taken alongsection B-B, shows only the two remaining lumens 14A and 14B. In thepresent embodiment, the loss of the lumen 14C accounts for the reducedouter diameter size of the catheter tube 12 in the reduced diameterportion 300 as the triple lumen catheter tube transitions to only adual-lumen catheter tube. The reduced diameter portion 300 in thepresent embodiment extends the remaining distal length of the cathetertube 12, though this may vary in other embodiments. Reduction of theouter diameter of the catheter tube 12 in the reduced diameter portion300 results in less occlusion of the vein or other vessel in which thecatheter tube is disposed, which in turn can reduce the incidence ofdeep vein thrombosis and other catheter-related complications. In otherembodiments, however, no reduction of the catheter tube size isnecessary.

It is thus appreciated that the lumen 14C is considered a terminatinglumen as it extends from the proximal end 12A of the catheter tube 12 tothe proximal end 300A of the reduced diameter portion 300, where itterminates at a closed, distal termination point, as seen in FIG. 3C. Soconfigured, the distal termination point of the lumen 14C provides alocation for the placement of a sensor 320 (FIG. 1, 3C) in the lumen,where it can be secured and be protected from removal from the cathetertube 12. Though in the present embodiment the lumen 14C remains separatefrom the other lumens 14A and 14B, the lumen 14C upon termination cancombine with another lumen or lumens in other embodiments.

As mentioned, the sensor 320 is placed in a distal portion of theterminating lumen 14C, as seen in FIGS. 1 and 3C, though otherplacements within the terminating lumen 14C are also possible. Thesensor 320 in the present embodiment is a temperature sensor formeasuring an internal body temperature of the patient when the catheterassembly 10 is disposed within the body of the patient. The sensor 320here is representative of a variety of types of sensors and electronicor medical components that can be placed in the terminating lumen toacquire data relating to the patient or to assist in patient care. Assuch, the disclosure herein is not intended to be limiting.

It is appreciated that in the present embodiment the terminating lumen14C is isolated from fluids transported through the catheter tube 12such that the sensor 320 is not in contact with such fluids. In otherembodiments, however, fluids could be inserted into the lumen ifdesired, recognizing that no outlet exists for such fluids other than atthe proximal portion of the catheter tube. Or a skive cut or other holecould be defined near the distal end of the terminating lumen in oneembodiment to enable direct contact of the sensor with blood of thepatient.

In yet another embodiment, the terminating lumen 14C could be extendedin length and open near the distal end 12B of the catheter tube 12,extend proximally as a lumen, and terminate at a relatively moreproximal portion of the catheter tube, effectively reversing theconfiguration shown in FIG. 3C, either with or without the reduceddiameter portion of the catheter tube. In yet another embodiment, afirst terminating lumen can extend distally from the proximal end of thecatheter tube, while another terminating lumen extends proximally fromor near the distal end of the catheter tube. These and otherconfigurations are contemplated.

Note that one or more of a variety of sensors can be included in theterminating lumen, including light-based sensors, glucose meters, bloodoxygen sensors, SvO2 sensors, temperature sensors, pressure sensors, CVPsensors, lactic acid sensor, thermistors, etc. Note further that use ofa terminating lumen as described herein obviates the use of potting toplug an otherwise patent lumen so a sensor could be placed therein. Assuch, the potential dislodgement of potting from the catheter tube lumenand entry into the vessel is avoided.

Note that the catheter assembly 10 of FIG. 1 includes the three lumens14A, 14B, and 14C extending distally from the proximal end thereof, butonly two extension legs 18. In the present embodiment, the lumens thatextend the length of the catheter tube 12, i.e., lumens 14A and 14B arecorrespondingly operably connected to the extension legs 18, while theterminating lumen 14C includes an access port at the bifurcation hub 16,but no extension leg. In other embodiment, the terminating lumen 14C canshare an extension with one of the other lumens, or can be sealed so asto include no access port, in one embodiment. These and othermodifications are contemplated.

It is appreciated that the catheter tube 12 and its lumen configurationas described above in connection with FIGS. 2-3C can be manufactured inone or more ways, though in one embodiment the lumen 14C is terminatedduring an extrusion process. Briefly, an extrusion material is extrudedthrough a properly configured die to form a continuous length ofcatheter tubing. Pins are positioned in the extrusion pathway to definethe various lumens of the catheter tubing, such as the lumens 14A, 14B,and 14C of the catheter assembly 10 shown in FIG. 1, for example. Theterminating lumen 14C is formed by removing the corresponding pin thatdefines the terminating lumen at the desired point during extrusion ofthe catheter tubing, while keeping the other pins for defining thelumens 14A and 14B in place. The pressure of injection air blown throughthe pins to keep the lumens inflated during the extrusion process,together with a pull rate of the catheter tubing as it is pulled fromthe extrusion machine, can be modified to maintain the catheter tubingand lumen configuration as desired. Once it has sufficiently cured, thecatheter tubing is cut into appropriate lengths to form the cathetertube, such as the catheter tube 12 shown in FIG. 1, with the terminatinglumen 14C present as has been described above. In another embodiment, nopin is removed; instead, the pull rate and/or injection air pressure areregulated so as to terminate one or more of the lumens along thelongitudinal length of the catheter tubing. Generally, it is appreciatedthat the catheter tube 12 can include more than one terminating lumen,with each of the lumens terminating at different termination pointsalong the length of the catheter tube.

FIGS. 4, 5A, and 5B depict details of a portion of the catheter tube 12according to another embodiment, wherein the outer diameter of thecatheter tube does not vary in diameter along its longitudinal length,in contrast to the catheter tube shown in FIG. 2. As shown by thecross-sectional view of the catheter tube 12 in FIG. 5A, which is takenalong the section A-A in FIG. 4, a relatively proximal portion of thecatheter tube defines three lumens 14A, 14B, and 14C. In contrast, arelatively more distal portion of the catheter tube 12, as shown by FIG.5B, which is taken along the section B-B in FIG. 4, defines only lumens14A and 14B, with the third lumen 14C having been terminated at a distaltermination point proximal to this cross section, thus becoming aterminating lumen.

Correspondingly, the lumen 14B as shown in FIG. 5B has increased in sizeto occupy the cross-sectional space formerly occupied by the lumen 14C.Thus, it is shown that not only can the number of lumens vary along thelongitudinal length of the catheter tube, but the relative sizes of thelumens can vary as well. As before, it is appreciated that the lumen 14Cterminates at a predetermined distal termination point along thelongitudinal length of the catheter tube 12 at a predetermined distancedistally from the proximal end 12A of the catheter tube. Such atermination point of the terminating lumen 14C provides a suitablelocation for the placement of a sensor, or for other purposes that maybe appreciated. The sensor may be placed in a relatively proximallocation within the terminating lumen so as to reside more peripherally(such as in the patient's arm) when the catheter tube is disposed withinthe patient body, or more distally (such as proximate the patient'sheart).

FIGS. 6A and 6B show another catheter tube lumen transitionconfiguration according to one embodiment, wherein a proximal portion ofthe catheter tube 12 includes a quad lumen configuration includinglumens 14A, 14B, 14C, and 14D, as shown in FIG. 6A. The third lumen 14Cis a terminating lumen and terminates at a distal termination point ofthe catheter tube 12 proximal to the cross section shown in FIG. 6B, inthe manner described above to transition the catheter tube to a triplelumen catheter tube including only lumens 14A, 14B, and 14D.Correspondingly, the sizes of the lumens 14A, 14B, and 14D are largerrelative their more proximal portions, made possible by the terminationof the third lumen 14C. It is appreciated that any one or more of thelumens can be terminated at any one of a variety of termination pointsalong the longitudinal length of the catheter tube 12 to produce atransitioning lumen catheter tube of a variety of configurations. Inanother embodiment, it is appreciated that one or more lumens can beadded at a relatively more distal point to a catheter tube includingfewer lumens in the proximal portion of the catheter tube. These andother modifications are contemplated.

FIGS. 7A and 7B show another catheter tube lumen transitionconfiguration according to one embodiment, wherein a proximal portion ofthe catheter tube 12 includes a quad lumen configuration includinglumens 14A, 14B, 14C, and 14D, as shown in FIG. 7A. The second lumen 14Band the third lumen 14C terminate at a more distal portion of thecatheter tube 12, as shown in FIG. 7B, in the manner described above totransition the catheter tube to a dual lumen catheter tube includingonly lumens 14A and 14D. Correspondingly, the sizes of the lumens 14Aand 14D are larger relative their more proximal portions, made possibleby the termination of the second and third lumens 14B, 14C.

Reference is now made to FIG. 8, which depicts the catheter tube 12according to one embodiment. As shown, the catheter tube 12 includes twofluid-carrying lumens 14 for infusion and/or aspiration of fluidstherethrough that are defined to extend substantially the longitudinallength of the catheter tube. Corresponding side outlets 316 are disposedthrough the catheter tube wall, as shown.

A sensor 320, such as those described further above, is disposed in adistal portion of the catheter tube 12 near a distal end 12B there. Inthe present embodiment, the sensor 320 is disposed in a pocket and isisolated from the lumens 14 so as to not be in fluid communicationtherewith, though in other embodiments it is appreciated that the sensorcan be placed in fluid communication with one or more fluid-carryinglumens.

A sensor lumen 310 is also included and extends substantially the lengthof the catheter tube 12 so as to provide a route along which a sensorwire 324 can extend through the catheter tube to the sensor 320 disposednear the distal end 12B thereof. This enables the sensor 320 to beelectrical powered and/or to provide a route by which data and/ormeasurements can be transmitted to outside the patient body. Note thatthe sensor wire 324 can extend past the proximal end 12A of the cathetertube 12 and include an appropriate connector to enable it to operablyconnect to a data measurement device or other suitable component, as maybe appreciated.

Note that the catheter tube 12 including the distally placed sensor 320shown in FIG. 8, can be formed in one embodiment by first extruding thecatheter tube, then placing the sensor 320 and sensor wire 324 in place.The distal end is then tipped, such as by rF tipping, to form the closeddistal end. In another embodiment, the closed distal end about thesensor 320 is formed by adding uncured silicone to the distal portion ofan extruded silicone catheter tube 12, shaping the distal end as needed(such as via a form, cup, or mold), then curing the silicone tip. In yetanother embodiment, the distal portion of the catheter tube 12,including the sensor 320, can first be formed, then joined to the opendistal end of the catheter tube 12 via solvent bonding, epoxy, or othersuitable adhesive. These techniques can also be applied to the otherembodiments discussed herein.

Variations to the configuration of the catheter tube 12 as depicted inFIG. 8 are also contemplated. FIG. 12 gives an example of this, whereinonly a single fluid-carrying lumen 14 is included, together with thesensor lumen 310, which is in on offset position. FIG. 13 shows thecatheter tube 12 as including three fluid-carrying lumens 14 with theoffset sensor lumen 310. And FIG. 14 shows the catheter tube 12 asincluding two fluid-carrying lumens 14 that exit to side openings 316, asingle fluid-carrying lumen 14 that exits at a distal end opening 318,and the sensor lumen 310 interposed therebetween. Note that any one ormore of the side openings 316/distal end opening 318 can include valvedopenings, in one embodiment. Also the lumens 14 can be configured so asto exit at side openings 316 (or other openings) at various distancesalong the length of the catheter tube. These and other configurationsare therefore appreciated as comprising part of the present disclosure.

FIG. 9 shows a cross-sectional view of the catheter tube 12 according toone embodiment, wherein three fluid-carrying lumens 14 are shown asdefined by a catheter tube wall 302 and septa 322, together with acentrally disposed sensor lumen 310. The sensor lumen 310 can be used asa conduit through which one or more wires can be extended to operablyconnect a sensor disposed in a distal (or other) portion of the cathetertube, such as the sensor 320 of FIG. 8, for instance.

The size, shape, location, and other configuration of the sensor lumen310 can vary from that shown in FIG. 9. Indeed, FIG. 10 depicts anotherpossible cross-sectional lumen configuration, wherein two fluid-carryinglumens 14 are included with a centrally disposed sensor lumen 310. FIG.11 depicts the catheter tube 12 including three fluid-carrying lumens 14and two sensor wires 324A, 324B disposed in and integrated with thecatheter tube wall 302 such that no sensor lumen is required, thusrequiring no size sacrifice for fluid-carrying lumens. FIGS. 18 and 19depict variations of this configuration, wherein the catheter tube 12defines two fluid-carrying lumens 14 and three sensor wires 324A, 324B,and 324 C integrated with the catheter tube wall 302 (FIG. 18) or onefluid-carrying lumen 14 and four sensor wires 324A, 324B, 324C, and324D.

FIG. 15 depicts the catheter tube 12 including three fluid-carryinglumens 14 and an offset sensor lumen 310. FIG. 16 depicts the cathetertube 12 including two fluid-carrying lumens 14 and an offset sensorlumen 310. FIG. 17 depicts the catheter tube 12 including a singlefluid-carrying lumen 14 and an offset sensor lumen 310.

It is appreciated that placement and configuration of the integratedsensor wire locations and/or sensor lumen can be implemented in avariety of ways. In one embodiment, the sensor wires can be integratedwith the septum 322 instead of the catheter tube wall 302. Also, morethan one sensor wire or sensor lumen can be included to operably connectone or more sensors. The wire can include one or more wires, such as ina twisted pair configuration, for example. The number of fluid-carryinglumens can also vary in size, shape, number, etc., as can the size,placement, and configuration of the sensor lumen itself. In addition,note that the size, position, and type of sensors included with thecatheter tube can vary from what is shown and described, as can theoutlets of the fluid-carrying lumens.

FIG. 20 shows the catheter tube 12 according to another embodiment,wherein three fluid-carrying lumens 14 are included, together with thesensor 320 disposed in a distal portion of the catheter tube. The sensorwire 324 extends along the length of an outer surface of the cathetertube 12 to the sensor 320. A cover material 330 is placed over thesensor wall on the other surface of the catheter tube 12. The covermaterial 330 can be selected of one of a variety of suitable materials,including polyurethane film, heat-shrink material, etc.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A catheter assembly, comprising: an elongatecatheter tube formed of a catheter tube material, the catheter tubedefining at least one fluid-carrying lumen extending between a proximalend and a distal end of the catheter tube; and at least one terminatinglumen defined by the catheter tube, the terminating lumen extending to aclosed termination point positioned intermediately between the proximaland distal ends of the catheter tube, the termination point beingdefined by the catheter tube material, the terminating lumen configuredto be isolated from fluids.
 2. The catheter assembly as defined in claim1, wherein the terminating lumen distally extends from a proximal end ofthe catheter tube.
 3. The catheter assembly as defined in claim 1,wherein the catheter tube is configured to be inserted into a body of apatient.
 4. The catheter assembly as defined in claim 3, wherein thetermination point of the terminating lumen is disposed within the bodyof a patient when the catheter assembly is disposed within the body ofthe patient.
 5. The catheter assembly as defined in claim 1, furthercomprising a sensor disposed in the terminating lumen.
 6. The catheterassembly as defined in claim 5, wherein the sensor is disposed proximatethe termination point of the terminating lumen.
 7. The catheter assemblyas defined in claim 5, wherein the sensor is at least one of alight-based sensor, a glucose meter, a blood oxygen sensor, atemperature sensor, and a thermistor.
 8. The catheter assembly asdefined in claim 5, further comprising at least one wire that extendsalong the terminating lumen configured to operably connect the sensor toan apparatus separate from the catheter assembly.
 9. The catheterassembly as defined in claim 1, wherein an outer diameter of thecatheter tube is reduced in size distal to the termination point of theterminating lumen.
 10. The catheter assembly as defined in claim 1,wherein the catheter tube includes a plurality of fluid-carrying lumens.11. The catheter assembly as defined in claim 10, wherein across-sectional size of at least one of the fluid-carrying lumenschanges at a point distal to the termination point of the terminatinglumen relative to a point proximal to the termination point of theterminating lumen.
 12. The catheter assembly as defined in claim 10,wherein cross-sectional sizes of the fluid-carrying lumens remainsubstantially the same at a point distal to the termination point of theterminating lumen relative to a point proximal to the termination pointof the terminating lumen.
 13. The catheter assembly as defined in claim1, wherein the terminating lumen includes an access port on a proximalportion of the catheter assembly.
 14. A catheter assembly, comprising:an elongate catheter tube; at least one fluid-carrying lumen extendingbetween a proximal end and a distal end of the catheter tube; at leastone sensor disposed in a distal portion of the catheter tube, the atleast one sensor configured to be isolated from fluids; and at least onesensor wire extending between a proximal portion of the catheter tubeand the at least one sensor.
 15. The catheter assembly as defined inclaim 14, wherein the at least one sensor wire is disposed in a sensorlumen, the sensor lumen being centrally disposed in the catheter tube.16. The catheter assembly as defined in claim 14, wherein the at leastone sensor wire is disposed in a sensor lumen, the sensor lumen beingdisposed in an offset configuration in the catheter tube.
 17. Thecatheter assembly as defined in claim 14, wherein the at least onefluid-carrying lumen includes a side hole opening proximate a distal endof the catheter tube, the at least one sensor disposed distal to theside hole opening.
 18. The catheter assembly as defined in claim 14,wherein the catheter tube includes at least two fluid-carrying lumens,at least one of the fluid-carrying lumens including a side hole openingproximate a distal end of the catheter tube, the at least one sensordisposed distal to the side hole opening, at least one of thefluid-carrying lumens including a distal end opening at the distal endof the catheter tube.
 19. The catheter assembly as defined in claim 14,wherein the sensor wire is integrated into at least one of a septum anda tube wall of the catheter tube.
 20. A catheter assembly, comprising:an elongate catheter tube defining at least one fluid-carrying lumenextending between a proximal end and a distal end of the catheter tube;at least one terminating lumen defined by the catheter tube, theterminating lumen distally extending from a proximal portion of thecatheter tube to a closed distal termination point positionedintermediately between the proximal and distal ends of the cathetertube, the terminating lumen configured to be isolated from fluids; asensor disposed in the terminating lumen; and a sensor wire operablyconnected to the sensor.
 21. The catheter assembly as defined in claim20, wherein the sensor is disposed proximate the termination point ofthe terminating lumen.
 22. The catheter assembly as defined in claim 21,wherein the terminating lumen distally extends from a proximal end ofthe catheter tube.
 23. The catheter assembly as defined in claim 22,wherein the catheter tube is configured to be inserted into a body of apatient.
 24. The catheter assembly as defined in claim 23, wherein thetermination point of the terminating lumen is disposed within the bodyof a patient when the catheter assembly is disposed within the body ofthe patient.
 25. The catheter assembly as defined in claim 23, whereinthe sensor is at least one of a light-based sensor, a glucose meter, ablood oxygen sensor, a temperature sensor, and a thermistor.
 26. Thecatheter assembly as defined in claim 20, wherein the at least onefluid-carrying lumen increases in cross-sectional size at a point distalto the termination point of the terminating lumen.
 27. The catheterassembly as defined in claim 20, wherein an outer diameter of thecatheter tube is reduced in size distal to the termination point of theterminating lumen.
 28. The catheter assembly as defined in claim 20,wherein the catheter tube includes a plurality of fluid-carrying lumens.29. The catheter assembly as defined in claim 28, wherein across-sectional size of at least one of the fluid-carrying lumenschanges at a point distal to the termination point of the terminatinglumen relative to a point proximal to the termination point of theterminating lumen.
 30. The catheter assembly as defined in claim 28,wherein cross-sectional sizes of the fluid-carrying lumens remainssubstantially the same at a point distal to the termination point of theterminating lumen relative to a point proximal to the termination pointof the terminating lumen.
 31. The catheter assembly as defined in claim20, wherein the sensor wire is disposed along an outer surface of thecatheter tube.
 32. The catheter assembly as defined in claim 31, whereinthe sensor wire is covered by a cover material including at least one ofa polyurethane film and a shrink material.
 33. A method formanufacturing a catheter tube, the method comprising: extrudingcontinuous tubing defining a plurality of lumens from an extrusionmaterial along an extrusion pathway, the extrusion pathway including aplurality of extrusion pins; while extruding the continuous tubing,removing at least one of the extrusion pins from the extrusion pathwayto reduce the number of lumens defined by the continuous tubing;altering at least one of a extrusion pull rate and an injection airpressure employed in extruding the continuous tubing after removal ofthe at least one extrusion pin; and cutting the continuous tubing todefine the catheter tube, the catheter tube including at least oneterminating lumen that terminates at an intermediate position between aproximal end and a distal end of the catheter tube.